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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device fluorescence in situ hybridization, topoisomerase ii alpha, gene amplification and deletion
Definition Topoisomerase ii alpha (top2a) fluorescence in situ hybridization (fish) kit is to detect the top2a gene copy number changes (amplification and deletion) in breast cancer using formalin-fixed, paraffin-embeded human breast cancer tissue specimen.
Product CodeNXG
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 3 0 0 1 1 0 0 0 0

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